EXHIBIT 10.2
GENERAL SERVICES AGREEMENT
This General Services Agreement ("Agreement") is made between Advanced
Viral Research Corporation, Inc - ADVR, which has a place of business at 000
Xxxxxxxxx Xxxxxxxxx Xxxxx, Xxxxxxx, Xxx Xxxx 00000, XXX (hereinafter "Sponsor"),
and Quintiles Israel Ltd. having its office at P.O.B 0000, Xxxxx Xxxxxxxxxx Xxxx
Xxxxxxx 00000, Xxxxxx (hereinafter "Quintiles"). When signed by both parties,
this Agreement will set forth the terms and conditions under which Quintiles
agrees to provide certain services to Sponsor as set forth herein.
RECITALS:
A. Sponsor is in the business of developing, manufacturing and/or
distributing pharmaceutical products, medical devices and/or biotechnology
products. Quintiles is in the business of providing clinical trial services,
research, and other services for the pharmaceutical, medical device and
biotechnology industries and has made significant, up-front investments in
technologies related to those industries, building on important inventions and
web-based technologies.
B. Sponsor and Quintiles desire to enter into this Agreement whereby
Quintiles will perform services relating to ADVR's three projects:
Phase I Clinical Trial of the Peptide Nucleic Acid Complex `Product R'
in Patient with Advanced-Stage Acquired Immunodeficiency Syndrome
Phase I Clinical Trial of the Peptide Nucleic Acid Complex `Product R'
in Patient with Advanced-Stage Hematopoietic Neoplasms
Phase I Clinical Trial of the Peptide Nucleic Acid Complex `Product R'
in Patient with Advanced-Stage Cancer, Preceded by a Pre-Phase I single
Injection Study (the "Project").
AGREEMENT:
1.0 SERVICES TO BE PROVIDED. The services to be performed
hereunder (the "Services") shall be specified in the Scope of
Work attached hereto as Attachment 1. Any responsibilities not
specifically transferred in this Agreement shall remain the
responsibility of Sponsor.
2.0 PAYMENT OF FEES AND EXPENSES. Sponsor will pay Quintiles for
fees, expenses and pass-through costs in accordance with the
budget and payment schedule attached hereto as Attachment 2.
Sponsor agrees that the budget and payment schedule will be
structured in an effort to maintain cash neutrality for
Quintiles (with respect to the payment of professional fees,
pass-through costs and otherwise). As a minimum requirement in
this context, if requested by Quintiles, Sponsor agrees that
it shall provide an up-front payment equal to fifteen percent
(15%) of the budget, which up front payment shall be credited
to Sponsor on the
final invoice. Quintiles will invoice Sponsor monthly for the
fees, expenses and pass-through costs incurred in performing
the Services, and Sponsor shall pay each invoice within thirty
(30) days of the date of the invoice. If any portion of an
invoice is disputed, then Sponsor shall pay the undisputed
amounts as set forth in the preceding sentence and the parties
shall use good faith efforts to reconcile the disputed amount
as soon as practicable. Sponsor shall pay Quintiles interest
in an amount equal to four percent (4%) above the LIBOR rate
per month of all undisputed amounts owing hereunder and not
paid when due (or the maximum lesser amount permitted by
applicable law). In the event that taxes or duties, of
whatever nature, are required to be withheld on payments made
pursuant to this Agreement by any state, federal, provincial
or foreign government, including, but not limited to, Value
Added Tax, Sponsor shall promptly pay said taxes and duties to
the appropriate taxing authority without any deduction to any
amount owed to Quintiles. Sponsor shall secure and deliver to
Quintiles any official receipt for any such taxes paid.
Quintiles shall send all invoices to the attention of Xxxx X.
Xxxxxxxxx at the following address: 000 Xxxxxxxxx Xxxxxxxxx
Xxxxx, Xxxxxxx, Xxx Xxxx 00000, XXX. Sponsor shall send all
payments to the following address: Quintiles Israel Ltd.
P.O.B. 0000, Xxxxx Xxxxxxxxxx Xxxx Xxxxxxx 00000, Xxxxxx.
3.0 TERM. This Agreement shall commence on the date it has been
signed by all parties and shall continue until the Services
are completed or until terminated by either party in
accordance with Section 17 below.
4.0 CHANGE ORDERS. Any change in the details of this Agreement or
the assumptions upon which this Agreement is based (including,
but not limited to, changes in an agreed starting date for the
Project or suspension of the Project by Sponsor) may require
changes in the budget and/or time lines, and shall require a
written amendment to the Agreement (a "Change Order"). Each
Change Order shall detail the requested changes to the
applicable task, responsibility, duty, budget, time line or
other matter. The Change Order will become effective upon the
execution of the Change Order by both parties, and Quintiles
will be given a reasonable period of time within which to
implement the changes. Both parties agree to act in good faith
and promptly when considering a Change Order requested by the
other party. Without limiting the foregoing, Sponsor agrees
that it will not unreasonably withhold approval of a Change
Order, even if it involves a fixed price contract, if the
proposed changes in budgets or time lines result from, among
other appropriate reasons, forces outside the reasonable
control of Quintiles or changes in the assumptions upon which
the initial budget or time lines were based, including, but
not limited to, the assumptions set forth in the budget or
timelines. Quintiles reserves the right to postpone effecting
material changes in the Project's scope until such time as the
parties agree to and execute the corresponding Change Order.
For any Change Order that affects the scope of the regulatory
obligations that have been transferred to Quintiles, Quintiles
and Sponsor shall execute a corresponding amendment to the
Transfer of Obligations Form. Sponsor shall file such
amendment where appropriate, or as required by law or
regulation.
2
5.0 CONFIDENTIALITY. It is understood that during the course of
this Agreement, Quintiles and its employees may be exposed to
data and information that are confidential and proprietary to
Sponsor. All such data and information (hereinafter "Sponsor
Confidential Information") written or verbal, tangible or
intangible, made available, disclosed, or otherwise made known
to Quintiles and its employees as a result of Services under
this Agreement shall be considered confidential and shall be
considered the sole property of Sponsor. All information
regarding Quintiles' operations, methods, and pricing and all
Quintiles' Property (as defined in Section 6.0 below),
disclosed by Quintiles to Sponsor in connection with this
Agreement is proprietary, confidential information belonging
to Quintiles (the "Quintiles Confidential Information", and
together with the Sponsor Confidential Information, the
"Confidential Information"). The Confidential Information
shall be used by the receiving party and its employees only
for purposes of performing the receiving party's obligations
hereunder. Each party agrees that it will not reveal, publish
or otherwise disclose the Confidential Information of the
other party to any third party without the prior written
consent of the disclosing party. Each party agrees that it
will not disclose the terms of this Agreement to any third
party without the written consent of the other party, which
shall not unreasonably be withheld. These obligations of
confidentiality and nondisclosure shall remain in effect for a
period of ten (10) years after the completion or termination
of the Agreement.
The foregoing obligations shall not apply to Confidential
Information to the extent that it: (a) is or becomes generally
available to the public other than as a result of a disclosure
by the receiving party; (b) becomes available to the receiving
party on a non-confidential basis from a source which is not
prohibited from disclosing such information; (c) was developed
independently of any disclosure by the disclosing party or was
known to the receiving party prior to its receipt from the
disclosing party, as shown by contemporaneous written
evidence; or, (d) is required by law or regulation to be
disclosed.
6.0 OWNERSHIP AND INVENTIONS. All data and information generated
or derived by Quintiles as the result of services performed by
Quintiles under this Agreement shall be and remain the
exclusive property of Sponsor. Any inventions that may evolve
from the data and information described above or as the result
of services performed by Quintiles under this Agreement shall
belong to Sponsor and Quintiles agrees to assign its rights in
all such inventions and/or related patents to Sponsor.
Notwithstanding the foregoing, Sponsor acknowledges that
Quintiles possesses certain inventions, processes, know-how,
trade secrets, improvements, other intellectual properties and
other assets, including but not limited to analytical methods,
procedures and techniques, procedure manuals, personnel data,
financial information, computer technical expertise and
software, which have been independently developed by Quintiles
and which relate to its business or operations (collectively
"Quintiles' Property"). Sponsor and Quintiles agree that any
Quintiles' Property or improvements thereto which are used,
improved,
3
modified or developed by Quintiles under or during the term of
this Agreement are the sole and exclusive property of
Quintiles.
7.0 RECORDS AND MATERIALS. At the completion of the Services by
Quintiles, all materials, information and all other data owned
by Sponsor, regardless of the method of storage or retrieval,
shall be delivered to Sponsor in such form as is then
currently in the possession of Quintiles, subject to the
payment obligations set forth in Section 2 herein.
Alternatively, at Sponsor' s written request, such materials
and data may be retained by Quintiles for Sponsor for an
agreed-upon time period, or disposed of pursuant to the
written directions of Sponsor. Sponsor shall pay the costs
associated with any of the above options and shall pay a
to-be-determined fee for storage by Quintiles of records and
materials after completion or termination of the Services.
Quintiles, however, reserves the right to retain, at its own
cost and subject to the confidentiality provisions herein,
copies of all materials that may be needed to satisfy
regulatory requirements or to resolve disputes regarding the
Services. Nothing in this Agreement shall be construed to
transfer from Sponsor to Quintiles any FDA or regulatory
record-keeping requirements unless such transfer is
specifically provided for in the applicable Transfer of
Obligations Form.
8.0 INDEPENDENT CONTRACTOR RELATIONSHIP. For the purposes of this
Agreement, the parties hereto are independent contractors and
nothing contained in this Agreement shall be construed to
place them in the relationship of partners, principal and
agent, employer/employee or joint venturers. Neither party
shall have the power or right to bind or obligate the other
party, and neither party shall hold itself out as having such
authority. If, however, Sponsor desires to conduct clinical
trials in one or more countries that require a local sponsor
or representative, and Sponsor requests that Quintiles or its
affiliates serve as its agent for that purpose, then Quintiles
may serve as Sponsor's agent for the purpose of fulfilling
local sponsor or representative duties. Sponsor shall pay
Quintiles for such local representative services at Quintiles'
standard daily rates, unless otherwise specified in the
attached Budget.
9.0 REGULATORY COMPLIANCE; INSPECTIONS. Quintiles agrees that its
Services will be conducted in compliance with all applicable
laws, rules and regulations, and with the standard of care
customary in the contract research organization industry. If
this study will be conducted under an FDA Investigational New
Drug Application ("IND") or Investigational Device Exemption
("IDE"), or any other FDA application, Quintiles represents
that it has a compliance plan in place regarding the FDA's
electronic records and signatures regulation, 21 CFR Part 11
("Part 11") and that it is working diligently to implement its
plan. Quintiles, however, is not responsible for the
compliance or non-compliance of applications or systems used
by third parties (including, but not limited to, investigative
sites or third party laboratories) unless such applications or
systems are owned by Quintiles. Quintiles shall process all
personal data in accordance with this Agreement or as
otherwise instructed by Sponsor or its affiliates in
compliance with the EU Data Protection Directive 95/46/EC and
any applicable national legislation enacted
4
thereunder ("Data Protection Legislation"). Sponsor represents
and affirms to Quintiles that Sponsor has complied with, and
will continue to comply with its obligations under the Data
Protection Legislation.
Quintiles' standard operating procedures will be used in
performance of the Services, unless otherwise specifically
stated in the Scope of Work. Quintiles certifies that it has
not been debarred under the Generic Drug Enforcement Act and
that it will not knowingly employ any person or entity that
has been so debarred to perform any Services under this
Agreement. Sponsor represents and certifies that it will not
require Quintiles to perform any assignments or tasks in a
manner that would violate any applicable law or regulation.
Sponsor further represents that it will cooperate with
Quintiles in taking any actions that Quintiles reasonably
believes are necessary to comply with the regulatory
obligations that have been transferred to Quintiles. If
Sponsor is transferring to Quintiles responsibility for any
regulatory obligations under United States laws or
regulations, Quintiles and Sponsor shall cooperate in the
completion of a Transfer of Obligations Form in conjunction
with this Agreement. Any such regulatory responsibilities not
specifically transferred in the Transfer of Obligations Form
shall remain the regulatory responsibility of Sponsor. The
Transfer of Obligations Form will be filed with the United
States Food and Drug Administration ("FDA") by Sponsor where
appropriate, or as required by law or regulation.
Each party acknowledges that the other party may respond
independently to any regulatory correspondence or inquiry in
which such party or its affiliates is named. Each party,
however, shall: a) notify the other party promptly of any
governmental or regulatory inspection or inquiry concerning
any study or Project of Sponsor in which Quintiles is
providing Services, including, but not limited to, inspections
of investigational sites or laboratories; b) forward to the
other party copies of any correspondence from any regulatory
or governmental agency relating to such a study or Project,
including, but not limited to, U.S. FDA Form 483 notices, and
any refusal to file, rejection or warning letters, even if
they do not specifically mention the other party; and, c)
obtain the written consent of the other party, which will not
unreasonably be withheld, before referring to the other party
or any of its affiliates in any regulatory correspondence.
Where reasonably practicable, each party will be given the
opportunity to have a representative present during any
regulatory inspection. Each party, however, acknowledges that
it may not direct the manner in which the other party fulfills
its obligations to permit inspection by governmental entities.
Each party agrees that, during an inspection by any regulatory
authority concerning any study or Project of Sponsor in which
Quintiles is providing Services, it will not disclose
information and materials that are not required to be
disclosed to such agency, without the prior consent of the
other party, which shall not unreasonably be withheld. Such
information and materials includes, but are not limited to,
the following: 1) financial data and pricing data (including,
but not limited to, the budget and payment schedule); 2) sales
data (other than shipment
5
data); and, 3) personnel data (other than data as to
qualification of technical and professional persons performing
functions subject to regulatory requirements).
During the term of this Agreement, Quintiles will permit
Sponsor's representatives (unless such representatives are
competitors of Quintiles) to examine or audit the work
performed hereunder and the facilities at which the work is
conducted upon reasonable advance notice during regular
business hours to determine that the Project assignment is
being conducted in accordance with the agreed task and that
the facilities are adequate. All information disclosed,
revealed to or ascertained by Sponsor in connection with any
such audit or examination or in connection with any
correspondence between Quintiles and any regulatory
authorities (including any FDA Form 483 notices) shall be
deemed to constitute Quintiles Confidential Information, for
purposes of this Agreement. Sponsor shall reimburse Quintiles
for its time and expenses (including reasonable attorney fees
and the costs of responding to findings) associated with any
inspection, audit or investigation relating to the Services
("Inspection") instigated by Sponsor or by a governmental
authority, unless such Investigation finds that Quintiles
breached this Agreement or any applicable law or regulation.
10.0 RELATIONSHIP WITH INVESTIGATORS. If Quintiles will be
obligated to contract with investigators or investigative
sites (collectively, "Investigators") then Quintiles will use
its standard Clinical Trial Agreement ("Global CTA") form, a
copy of which can be reviewed on request along with certain
local CTA forms ("Local CTAs") that have developed for use in
certain countries based on local requirements with the benefit
of local legal advice, which have been prepared in local
language and English language where applicable. Any applicable
Local CTAs will be made available for inspection by the
Sponsor upon request. If the Global CTA form or a Local CTA is
updated, Quintiles will use its then current Global CTA form
(or Local CTA as appropriate) as of the time of the agreement.
If Sponsor insists that any CTA form other than the Global CTA
and Local CTAs be used, then Sponsor shall pay all translation
costs and additional negotiation time may be required. If an
Investigator insists upon any material changes to any
provisions that directly affect Sponsor, then Quintiles shall
submit the proposed material change to Sponsor, and Sponsor
shall review, comment on and/or approve such proposed changes
within five (5) working days. If the Global CTA form (or Local
CTA, where applicable), or any changes approved by Sponsor,
differ from the terms of this Agreement (including, but not
limited to, provisions allowing an Investigator to publish
results or data that Quintiles is prohibited from revealing),
then Quintiles shall have no liability for any such approved
provisions or changes. Unless otherwise stated in the attached
Budget, the time incurred by Quintiles in negotiating CTA
changes proposed by sites shall be billed at Quintiles'
Standard Rates. The parties acknowledge and agree that
Investigators shall not be considered the employees, agents,
or subcontractors of Quintiles or Sponsor and that
Investigators shall exercise their own independent medical
judgment. Quintiles' responsibilities with respect to
Investigators shall be limited to those responsibilities
specifically set forth in this Agreement.
6
If Quintiles will be paying Investigators on behalf of
Sponsor, the parties will agree in the attached Payment
Schedule as to a schedule of amounts to be paid to
Investigators. Sponsor acknowledges and agrees Quintiles will
only pay Investigators from advances or pre-payments received
from Sponsor for Investigators' services, and that Quintiles
will not make payments to Investigators prior to receipt of
sufficient funds from Sponsor. Sponsor acknowledges and agrees
that Quintiles will not be responsible for delays in a study
or Project to the extent that such delays are caused by
Sponsor's failure to make adequate pre-payment for
Investigators' services. Sponsor further acknowledges and
agrees that payments for Investigators' services are
pass-through payments to third parties and are separate from
payments for Quintiles' Services. Sponsor agrees that it will
not withhold Investigator payments except to the extent that
it has reasonable questions about the services performed by a
particular Investigator. For the avoidance of doubt, nothing
contained in this clause, or elsewhere in this Agreement, is
intended to confer any right or benefit on any third party
including, but not limited to, any Investigator, whether under
the provisions of the Contracts (Rights of Third Parties) Xxx
0000 or otherwise.
11.0 THIRD PARTY INDEMNIFICATIONS AND AGREEMENTS. If any
investigative sites or any other third parties, including, but
not limited to, Data Safety Monitoring Boards, independent
laboratories, Advisory Boards, or End Point Adjudication
Committees (collectively, "Third Parties"), request an
indemnification for loss or damage caused by the sponsor's
Project, then Sponsor shall provide such indemnification
directly to the Third Party. If Sponsor requests Quintiles'
assistance in negotiating the terms of such indemnities,
Quintiles shall provide such negotiation services at its
standard daily rates, unless otherwise agreed in the attached
Budget. Quintiles shall not sign such indemnifications on
Sponsor's behalf unless Sponsor has expressly authorized
Quintiles to act as its agent for such purpose or has given
Quintiles a written power of attorney to sign such
indemnifications. In countries in which local laws or local
ethics committees require that a local company must sign such
indemnifications and Sponsor has no local presence, Quintiles
will sign such indemnities only if the parties have entered
into an agreement regarding local representative duties. Such
agreement can be reviewed on request.
If Sponsor requests that Quintiles enter into agreements to
retain Third Parties to perform services regarding the
Project, such Third Parties shall be independent contractors
and shall not be considered the employees, agents, or
subcontractors of Quintiles or Sponsor. Sponsor shall pay
Quintiles for its reasonable time and expenses in negotiating
and administering any such Third Party Agreements.
12.0 CONFLICT OF AGREEMENTS. Quintiles represents to Sponsor that
it is not a party to any agreement which would prevent it from
fulfilling its obligations under this Agreement and that
during the term of this Agreement, Quintiles agrees that it
will not enter into any agreement to provide services which
would in any way prevent it from providing the Services
contemplated under this Agreement.
7
Sponsor agrees that it will not enter into an agreement with a
third party that would alter or affect the regulatory
obligations delegated to Quintiles pursuant to this Agreement
without the written consent of Quintiles, which will not be
unreasonably withheld.
13.0 PUBLICATION. Project results may not be published or referred
to, in whole or in part, by Quintiles or its affiliates
without the prior expressed written consent of Sponsor.
Neither party will use the other party's name in connection
with any publication or promotion without the other party's
prior, written consent.
14.0 LIMITATION OF LIABILITY. Neither Quintiles, nor its
affiliates, nor any of Quintiles' or, its affiliate's
directors, officers, employees, subcontractors or agents shall
have any liability of any type to the extent that such
liabilities have not resulted from Quintiles' negligence or
intentional misconduct, for any loss of profits, opportunity
or goodwill, or any type of special, incidental, indirect or
consequential damage or loss in connection with or arising out
of this Agreement or the Services performed by Quintiles
hereunder.
15.0 INDEMNIFICATION. Sponsor shall indemnify, defend and hold
harmless Quintiles and its affiliates, and its and their
directors, officers, employees and agents (each, a "Quintiles
Indemnified Party"), from and against any and all losses,
damages, liabilities, reasonable attorney fees, court costs,
and expenses (collectively "Losses"), joint or several,
resulting or arising from any third-party claims, actions,
proceedings, investigations or litigation relating to or
arising from or in connection with the Services furnished by
Quintiles under this Agreement (including, without limitation,
any Losses arising from or in connection with any study, test,
device, product or potential product to which this Agreement
relates), provided, however, that (1) Quintiles is shown to
have adhered to and complied with all applicable rules and
regulations, (2) that Sponsor is promptly notified in writing
of any such claim or suit, and (3) that Quintiles agrees to
fully cooperate in the handling of any such claim and in the
event of suit, to attend hearings and trials and assist in
securing and giving evidence and in obtaining the attendance
of necessary and proper witnesses. This agreement by Sponsor
to indemnify and to hold harmless shall not cover Losses that
are determined to have resulted solely from the negligence or
intentional misconduct of the Quintiles Indemnified Party
seeking indemnity hereunder.
16.0 INDEMNIFICATION PROCEDURE. Quintiles shall give Sponsor prompt
notice of any such claim or lawsuit (including a copy thereof)
served upon it and shall fully cooperate with Sponsor and its
legal representatives in the investigation of any matter the
subject of indemnification. Quintiles shall not unreasonably
withhold its approval of the settlement of any claim,
liability, or action covered by this Indemnification
provision.
17.0 TERMINATION. Sponsor or Quintiles may terminate this Agreement
without cause at any time during the term of the Agreement on
sixty (60) day's prior written notice
8
to Quintiles or Sponsor, as appropriate. Either party may
terminate this Agreement for material breach upon thirty (30)
days' written notice specifying the nature of the breach, if
such breach has not been substantially cured within the thirty
(30) day period. During the 30-day cure period for termination
due to breach, each party will continue to perform its
obligations under the Agreement. If the termination notice is
not due to a breach, or if the cure period has expired without
a substantial cure of the breach, then the parties shall
promptly meet to prepare a close-out schedule, and Quintiles
shall cease performing all work not necessary for the orderly
close-out of the Services or required by laws or regulations.
If Quintiles determines that its continued performance of the
Services contemplated by this Agreement would constitute a
potential or actual violation of regulatory or scientific
standards of integrity, then Quintiles may terminate this
Agreement by giving written notice stating the effective date
(which may be less than thirty days but at least fifteen days
from the notice date) of such termination and the basis for
such termination, provided that such violation will not result
from Quintiles' misconduct and there is a reasonable belief
that such violation is likely to occur. Either party may
terminate this Agreement immediately upon provision of written
notice if the other party becomes insolvent or files for
bankruptcy.
If this Agreement is terminated by Sponsor without cause or by
Quintiles for cause, Sponsor shall pay Quintiles for all
Services performed in accordance with the payment schedule
indicated in Attachment 2 of this Agreement and reimburse
Quintiles for all costs and expenses incurred in performing
those Services, including all non-cancelable costs incurred
prior to termination but paid after the termination date.
Under no circumstance the amount of the payment shall exceed
the cap specified in Attachment 2 of this Agreement.
18.0 RELATIONSHIP WITH AFFILIATES. Sponsor agrees that Quintiles
may use the Services of its corporate affiliates to fulfill
Quintiles' obligations under this Agreement. Any affiliate so
used shall be subject to all of the terms and conditions
applicable to Quintiles under this Agreement and entitled to
all rights and protections afforded Quintiles under this
Agreement. The term "affiliate" shall mean all entities
controlling, controlled by or under common control with
Quintiles. The term "control" shall mean the ability to vote
fifty percent (50%) or more of the voting securities of any
entity or otherwise having the ability to influence and direct
the polices and direction of an entity.
19.0 COOPERATION; SPONSOR DELAYS; DISCLOSURE OF HAZARDS. Sponsor
shall forward to Quintiles in a timely manner all documents,
materials and information in Sponsor's possession or control
necessary for Quintiles to conduct the Services. Quintiles
shall not be liable to Sponsor nor be deemed to have breached
this Agreement for errors, delays or other consequences
arising from Sponsor's failure to timely provide documents,
materials or information or to otherwise cooperate with
Quintiles in order for Quintiles to timely and properly
perform its obligations. If Sponsor delays a project from its
agreed starting date or suspends
9
performance of the project for a period longer than 10 working
days, then either: a) Sponsor will pay the standard daily rate
of the Quintiles' personnel assigned to the project, based on
the percentage of their time allocated to the project, for the
period of the delay beginning on the eleventh working day, in
order to keep the current team members; or, b) Quintiles may
re-allocate the personnel at its discretion, and Sponsor will
pay the costs of re-training new personnel. In addition,
Sponsor will pay all non-cancelable costs and expenses
incurred by Quintiles due to the delay and will adjust all
timelines to reflect additional time required due to the
delay. In order for Quintiles to comply with the Health and
Safety at Work Xxx 0000 and any applicable regulation made
pursuant thereto it is a condition of Quintiles providing the
contract Services that Sponsor shall provide Quintiles with
all information available to it regarding known or potential
hazards associated with the use of any substances supplied to
Quintiles by Sponsor, and Sponsor shall comply with all
current legislation and regulations concerning the shipment of
substances by the land, sea or air.
20.0 PERFORMANCE. Quintiles shall use reasonable efforts to perform
the Service in accordance with the terms and conditions of
this Agreement, and promptly report in writing to Sponsor upon
completion of each task listed in the Table of
Responsibilities of Attachment 1 of this Agreement.
21.0 FORCE MAJEURE. In the event either party shall be delayed or
hindered in or prevented from the performance of any act
required hereunder by reasons of strike, lockouts, labor
troubles, inability to procure materials or services, failure
of power or restrictive government or judicial orders, or
decrees, riots, insurrection, war, Acts of God, inclement
weather or other reason or cause beyond that party's control,
then performance of such act (except for the payment of money
owed) shall be excused for the period of such delay.
22.0 NOTICES AND DELIVERIES. Any notice required or permitted to be
given hereunder by either party hereunder shall be in writing
and shall be deemed given on the date received if delivered
personally or by a reputable overnight delivery service, or
three (3) days after the date postmarked if sent by registered
or certified mail, return receipt requested, postage prepaid
to the following addresses:
If to Quintiles: Hagit Nof
If to Sponsor: Xx. Xxxxxx X. Xxxxxxxxx
If Sponsor delivers, ships, or mails materials or documents to
Quintiles, or requests that Quintiles deliver, ship, or mail
materials or documents to Sponsor or to third parties, then
the expense and risk of loss for such deliveries, shipments,
or mailings shall be borne by Sponsor. Quintiles disclaims any
liability for the actions or omissions of third-party delivery
services or carriers.
23.0 INSURANCE. During the term of this Agreement to cover its
obligations hereunder, each party shall maintain insurance
coverage with a reputable insurance company. The insured party
will, upon specific written request, provide evidence in the
form
10
of a certificate of insurance that the other party is an
additional insured on the insured party's policy/policies as
their interests may appear.
24.0 FOREIGN CURRENCY EXCHANGE. The currency to be used to invoice
and for payment shall be set forth in the Budget attached
hereto as part of Attachment 1 (the "Budget"). If Quintiles is
to perform services whereby it earns fees or incurs expenses
in a currency(ies) differing from the invoice and payment
currency (hereafter, "foreign currency(ies)"), the initial
foreign currency exchange rates used as a basis for
calculating the Budget shall be referred to as the "Budgeted
Rate". For this Agreement, the Budgeted Rate is as follows:
[INSERT RATE]. In addition the Budget will state for each
currency its percentage of the total fees (and expenses, if
applicable), after its conversion into the invoice and payment
currency, which will be applied to all invoices. If a currency
referenced within the Budget is replaced by the Euro or
otherwise ceases to become legal tender, the applicable
replacement currency will be substituted for such currency for
purposes of this provision at an established conversion rate.
Each end of month, an average actual foreign exchange rate
will be computed for each foreign currency exchange rate
indicated in the Budget. The actual foreign currency exchange
rate will be calculated based upon the foreign currency
exchange spot rates published at XXX.XXXXX.XXX on the last
business Friday of each month (the "Current Rates").
25.0 INFLATION ADJUSTMENTS. If Services are provided by Quintiles
over multiple calendar years, Quintiles may increase its fees
at the beginning of each calendar year to reflect increases in
Quintiles' business costs on a prospective basis only.
Quintiles' overall costs may be increased for the next twelve
(12) month period using the greater of four percent (4%) or
the average percentage change in the wages/earnings survey as
published in the Economist (or as reported at
XXX.XXXXXXXXX.XXX or the equivalent inflation index of the
country where services are performed, over the preceding
twelve (12) month period.
26.0 BINDING AGREEMENT AND ASSIGNMENT. This Agreement shall be
binding upon and inure to the benefit of Sponsor and Quintiles
and their respective successors and permitted assigns. Except
as stated above in Section 18, neither party may assign any of
its rights or obligations under this Agreement to any party
without the express, written consent of the other party.
27.0 CHOICE OF LAW, WAIVER AND ENFORCEABILITY. This Agreement shall
be construed, governed, interpreted, and applied in accordance
with the laws of Israel exclusive of its conflicts of law
provisions. The failure to enforce any right or provision
herein shall not constitute a waiver of that right or
provision. Any waiver of a breach of a provision shall not
constitute a waiver of any subsequent breach of that
provision. If any provisions herein are found to be
unenforceable on the grounds that they are overly broad or in
conflict with applicable laws, it is the intent of the parties
that such provisions be replaced, reformed or narrowed so that
11
their original business purpose can be accomplished to the
extent permitted by law, and that the remaining provisions
shall not in any way be affected or impaired thereby.
28.0 SURVIVAL. The rights and obligations of Sponsor and Quintiles,
which by intent or meaning have validity beyond such
termination (including, but not limited to, rights with
respect to inventions, confidentiality, discoveries and
improvements, indemnification and liability limitations) shall
survive the termination of this Agreement.
29.0 ARBITRATION. Any controversy or claim arising out of or
relating to this Agreement or the breach thereof shall be
settled by arbitration administered by the International
Chamber of Commerce ("ICC") under its International Rules of
Arbitration, and judgment on the award rendered by the
arbitrator shall be binding and may be entered in any court
having jurisdiction thereof. Such arbitration shall be filed
and conducted at the office of the ICC closest to the
Quintiles office having responsibility for the Project, and
shall be conducted in English by one arbitrator mutually
acceptable to the parties selected in accordance with ICC
Rules.
30.0 ENTIRE AGREEMENT, HEADINGS AND MODIFICATION. This Agreement
contains the entire understandings of the parties with respect
to the subject matter herein, and supersedes all previous
agreements (oral and written), negotiations and discussions.
The descriptive headings of the sections of this Agreement are
inserted for convenience only and shall not control or affect
the meaning or construction of any provision hereof. Any
modifications to the provisions herein must be in writing and
signed by the parties.
12
IN WITNESS WHEREOF, this Agreement has been executed by the parties hereto
through their duly authorized officers on the date(s) set forth below.
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
[INSERT SPONSOR'S FULL LEGAL NAME]
Quintiles Israel Ltd. Advanced Viral Research Corp.
ID - 051256654
By: /s/ XXXX XXXXXXXX By: /s/ XXXXXX X. XXXXXXXXX, M.D.
-------------------------------- --------------------------------
Print Name: XXXX XXXXXXXX Print Name: XXXXXX X. XXXXXXXXX
------------------------ ------------------------
Title: GENERAL MANAGER Title: PRESIDENT AND CEO
----------------------------- -----------------------------
Date: OCTOBER 8, 2002 Date: OCTOBER 4, 2002
------------------------------ ------------------------------
LIST OF ATTACHMENTS
ATTACHMENT 1 - SCOPE OF WORK (FINAL PROPOSAL)
ATTACHMENT 2 - PAYMENT SCHEDULE
ATTACHMENT 3 - QUINTILES ICH-GCP COMPLIANCE
13
